AMZEEQ®
(minocycline) topical foam, 4%

Amzeeq

The First Topical Minocycline

AMZEEQ® (minocycline) topical foam, 4% is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older.

Limitations of Use:  This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated.

Acne is a chronic, inflammatory skin condition that affects the skin’s oil glands and hair follicles. It is characterized by both inflammatory lesions (papules and pustules) and non-inflammatory lesions (open and closed comedones) affecting primarily the face and other areas of the body. Acne affects approximately 40 to 50 million people in the U.S. alone, of whom approximately 10 million have moderate to severe disease that may impact self-esteem and quality of life. For most people, acne diminishes over time and tends to disappear or decrease, by age 25. However, some individuals, particularly women, can experience acne much later in life.

Oral minocycline is well established as an efficacious acne treatment, and now available topically

  • In three 12-week studies of 2,418 patients, Amzeeq demonstrated an improvement vs. vehicle foam in both inflammatory lesions and IGA scores.1*
  • The most commonly reported adverse reaction was headache (3%).1

Surfactant free formulation5

  • Proprietary oil-based foam vehicle contains natural moisturizing ingredients, such as coconut oil and soybean oil, without drying agents like ethyl alcohol.1,2†

Novel Molecule Stabilizing Technology (MST)™ Delivery

  • Molecule Stabilizing Technology (MST)™ enables minocycline to be placed into a lipophilic vehicle for stable topical delivery.3,4

IMPORTANT SAFETY INFORMATION

Indication

AMZEEQ is a topical form of the antibiotic minocycline for the treatment of pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne in adults and children 9 years of age and older.  AMZEEQ is available by prescription only.

AMZEEQ should not be used for the treatment of infections. It is not known if AMZEEQ is safe and effective in children under 9 years of age. AMZEEQ is for use on skin only (topical use). AMZEEQ is not for use in the mouth, eyes or vagina.

Important Safety Information

  • AMZEEQ should not be used in people who are allergic to AMZEEQ or any tetracycline medicine. Use of AMZEEQ should be stopped right away if a rash or other allergic symptom occurs.
  • AMZEEQ should not be used in women who are pregnant, may become pregnant or are nursing. If a woman becomes pregnant while using AMZEEQ, she should talk to her doctor. Tetracycline medicine when taken by mouth during pregnancy, infancy and/or childhood up to the age of 8 years may permanently discolor teeth (yellow-gray-brown) and may slow the growth of bones.
  • AMZEEQ is flammable and fire, flame, and smoking must be avoided when applying and right after applying AMZEEQ.
  • People should protect their skin from the sun while using AMZEEQ and avoid sunlight or artificial sunlight such as sunlamps or tanning beds. Use of AMZEEQ should be stopped if skin is sunburned.
  • When taken by mouth, minocycline may cause feelings of lightheadedness, dizziness or spinning. People should not drive or operate dangerous machinery if they have these symptoms.

AMZEEQ is a topical foam that contains minocycline, a tetracycline medicine. It is not taken by mouth.  However, tetracyclines, when taken by mouth (capsules or tablets), may cause serious side effects, including: diarrhea, including  watery or bloody stools;  loss of appetite; tiredness; yellowing of the skin or eyes; bleeding more easily than normal; confusion; sleepiness;  vision changes, including blurred vision, double vision, or permanent vision loss; unusual headaches; fever; rash; joint pain; body weakness; discoloration or darkening of the skin, scars, teeth, or gums. People should call their doctor right away if these side effects occur.

The most common side effect of AMZEEQ is headache.

These are not all of the possible side effects with AMZEEQ. People should contact their doctor for medical advice about side effects and be sure to tell their doctor about all of their medical conditions and medicines they take before using AMZEEQ.

People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information and Patient Information.

*Coprimary endpoints at Week 12 were: Absolute change from baseline in inflammatory lesion count and Investigator’s Global Assessment (IGA) treatment success. IGA treatment success was defined as an IGA score of 0 or 1 (clear or almost clear), and at least a 2-grade improvement (decrease) from baseline at Week 12. Subjects were required to have 20-50 inflammatory lesions (papules, pustules, nodules) and 25-100 noninflammatory lesions (open, closed comedones) and an IGA score on a 6-point scale of moderate or severe (grade 3 or 4) at baseline.

†Amzeeq 4% topical foam contains the following inactive ingredients: soybean oil, coconut oil, light mineral oil, cyclomethicone, cetostearyl alcohol, stearic acid, myristyl alcohol, hydrogenated castor oil, white wax (beeswax), stearyl alcohol, docosanol, and propellants (butane + isobutane + propane).

References:

  1. Amzeeq® (minocycline) topical foam, 4% Prescribing Information. Bridgewater, NJ: Foamix Pharmaceuticals, Inc; 2019.
  2. Lin TK, et al. Int J Mol Sci. 2017;19(1). pii: E70. doi: 10.3390/ijms19010070.
  3. Moribe K, et al. Chem Pharm Bull. 2010;58(8):1096-1099.
  4. Yokota J, et al. J Chin Med Assoc. 2018;81:511e519.
  5. Hazot Y, et al. J Anal Pharm Res. 2017;4(5):00117.
  6. Bickers DR, Lim HW, Margolis D, Weinstock MA, Goodman C, Faulkner E, et al. JAAD. 2006;55:490-500.

Intended only for US residents.
AMZEEQ is a registered trademark of Foamix Pharmaceuticals Ltd. (a wholly owned subsidiary of VYNE Therapeutics™ Inc.)
© 2020 VYNE Therapeutics Inc. All Rights Reserved.

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COM-AMZ-US-200125 09/2020